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Director, Clinical Data Management
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Design, Sql
Projektbeschreibung
* Responsible for managing, planning and coordinating the activities of the Data Management group
* Responsible for ensuring the data collected is error free and meets the requirements of the study sponsor and internal Novum quality standards.
* Ensure that the Data Management group is aligned with business objectives as well as in compliance with all FDA requirements.
* Work closely with management to prepare and execute data management plans to manage projects from beginning to end.
* Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
* Work closely with Clinical Trials Division and Statisticians and other staff as appropriate to develop CRF's to ensure the information required for statistical analysis is present.
* Co-ordinate with database programmers/QA to create and validate database design and edit check specifications.
* Oversee hiring, daily management, training and development of data management staff.
* Oversee coding of safety data using industry standard coding directions.
* Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
* Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
* Assist with the validation of the statistical output for the final report.
* Other duties as assigned.
Qualifications
* At least 7 years in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management.
* At least 3 years experience managing a data management group. Experience in a service environment would be preferable.
* Working knowledge of Word Processing software, Microsoft Project, e-mail software, Microsoft Access, and Microsoft Excel. Practical experience with SQL and SAS required.
* Excellent organizational skills with a demonstrated ability to manage staff, projects and resources to meet timelines and budgets.
* Effective problem solving, collaboration and teamwork skills.
* Ability to travel up to 20% as needed.
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Pittsburgh, Pennsylvania, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design